[Congressional Record Volume 143, Number 108 (Monday, July 28, 1997)]
[Senate]
[Pages S8162-S8170]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF 
                                  1997

  Mr. DURBIN. Mr. President, I would like to say at the outset that I 
have the highest respect for the Senator from Vermont. The Senator has 
done a great deal of work on one of the most important pieces of 
legislation which we will consider during the course of this Congress. 
Although I am not a member of his committee, I have an abiding interest 
in the Food and Drug Administration. For 12 years in the House I was a 
member of the subcommittee which funded the Food and Drug 
Administration. I was called on many times to get involved in issues 
related to this important agency.
  It is an extraordinary agency. By Federal standards it is tiny. About 
$1 billion each year out of our $1.6 trillion budget is spent on the 
budget of the Food and Drug Administration. Yet every one of us, every 
American family, depends on the Food and Drug Administration. Many of 
the products which we take for granted are reviewed by them for safety 
so that our families can use them and feel confident that the product 
is safe for that use. Thus, when there have been efforts to reform the 
Food and Drug Administration, I have been very attentive. Some people 
are looking to reform the Food and Drug Administration for selfish 
reasons. Others are looking to reform the Food and Drug Administration 
for the right reasons. I believe the Senator from Vermont falls in the 
latter category. I believe he is trying to reform the FDA for the right 
reasons.
  He and I may have a few differences of opinion, I think very few, and 
I hope that we have a chance, when this bill comes to the floor, to 
actually address them and perhaps, in the quiet of an off-the-floor 
conversation, we may come to an agreement on each of these items that I 
would like to discuss. But I salute him for the hard work which he has 
done in a bipartisan fashion to bring this matter to the floor.
  It is my understanding, perhaps the Senator from Vermont could 
enlighten us, that the bill itself was not ready for consideration, was 
actually in draft form for Members' offices to read, until this 
weekend. And, if that is the case, although I would like to see us move 
on it this week, I'm sure we would all like at least a few moments to 
go through it and to reflect on the different changes that are proposed 
and the impact that they would have on this important agency.
  Mr. JEFFORDS. If the Senator will yield?
  Mr. DURBIN. I would be happy to yield for a question.
  Mr. JEFFORDS. The bill itself has been ready for about a month and 
has been under examination for a month. In order to be able to proceed 
most efficiently and effectively in the amendment process, we have been 
working with Members--and you have asked us to do so today--to take 
into consideration possible changes in the bill. We had many requests 
of that nature over the past month, and we have accommodated, to my 
knowledge, every one of those requests and have been and are ready to 
proceed, with the understanding that certain amendments would be 
offered. Some of those amendments would be accepted and some of those 
would be disagreed with.
  But we are under the exigencies of time here. This is such an 
important bill. We started negotiations, the Senate did, last year, 
under Senator Kassebaum. The bill was voted out of the committee by a 
very substantial vote. However, there were strong objections raised to 
it and problems with the House. So we started again this year with the 
bill and we have been working for several months, now, ironing out 
these difficulties and problems.
  It was my understanding we had a consensus. That is why we are here 
on the floor this afternoon. On the other hand, now we understand that 
some others have reasons that they would like to participate. We have 
no problem with that. The problem is not ours, in the sense of the 
committee. The problem is time on the floor. We have just 1 week left 
before we go into recess in order to accomplish the major bills, the 
reconciliation and budget matters, and we will have only a limited 
amount of time. So, for us to proceed and get this finished by the end 
of the week, which is important, it is going to take agreement by those 
who now want to participate in order to have a timely process where we 
can bring this to conclusion.
  I look forward to working with my colleague--I know he will cooperate

[[Page S8163]]

with us so that this very important piece of legislation can get passed 
out. The House is waiting to move until we move. Also connected with it 
is the Prescription Drug User Fee Act, PDUFA, which is very important 
to get passed because that expires at the end of September. So we must 
move ahead. I thank the Senator for giving his time.
  Mr. DURBIN. If the Senator from Vermont will continue to yield for 
the purpose of a question, then it is my understanding we will not 
proceed to the bill itself today, that we will wait?
  Mr. JEFFORDS. I am not proceeding to the bill at this time. I am 
hopeful and wait patiently with great expectations that at some point 
after having discussed with you and perhaps communicated with the 
minority leader that we will be able to move forward with the bill in a 
way that will utilize the time today effectively so that we can 
complete this bill by the end of the week. But I do not intend to call 
it up at this particular moment.
  Mr. DURBIN. I thank the Senator from Vermont and pledge my 
cooperation to consider any amendments which might be necessary to be 
debated on the floor in a timely manner, sensitive to the limited time 
we have this week. He is correct, that if we do not move on this user 
fee question, it will expire and create great problems and 
complications at this important agency. We don't want that to happen. I 
share with him the belief that we can and should move this bill forward 
this week, and I look forward to working with him.


                         Privilege of the Floor

  Mr. DURBIN. Mr. President, I ask unanimous consent that Anne Marie 
Murphy of my staff be accorded the privilege of the floor for the 
duration of debate, when it starts, on S. 830, the Food and Drug 
Administration Modernization and Accountability Act of 1997.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.


                         Privilege of the Floor

  Mr. JEFFORDS. Mr. President, I ask unanimous consent that Sean 
Donohue and Chris Loso, fellows with the Committee on Labor and Human 
Resources, be permitted the privilege of the floor during all Senate 
consideration of S. 830, the Food and Drug Modernization and 
Accountability Act.
  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. JEFFORDS. Mr. President, as we have just discussed, I am going to 
proceed so that my colleagues and those interested in this legislation 
can better understand the nature of this legislation and the importance 
of it, and, hopefully, later in the day, we will be able to proceed in 
an orderly manner through the amendment process.
  The legislation is to modernize the Food and Drug Administration, and 
we authorize the Prescription Drug User Fee Act, which will, upon 
enactment, streamline the FDA's regulatory procedures. This 
modernization will help the agency review medical devices and drugs 
more expeditiously and will let the American public have access sooner 
to newer, safer and more effective therapeutic products.
  I am disappointed that some of my Democratic colleagues are not 
desirous of proceeding at this time, but I will do my best to 
accommodate them and also to move forward on this bill. I am especially 
chagrined, given the months of bipartisan negotiating that has led to 
this bill. Each major provision--all of the drugs and medical device 
provisions of this measure--represents long-sought agreements with the 
minority and with the FDA itself. I do not understand this continued 
delay.
  In particular, Senator Kennedy has played a key role in reaching this 
agreement, and I wish to applaud his willingness and tenacity in 
working through several difficult issues to reach a consensus on this 
legislation.
  In addition, Secretary Shalala and the FDA itself has worked 
diligently to reach reasonable, sensible agreements. This is a good, 
bipartisan measure that represents moderate yet real reform. It has 
been agreed to by the minority and the administration.
  There is no reason for further delay, and I am going forward today 
with the expectation that before the end of the day, we will be moving 
forward on this bill.
  On June 11, prior to the committee markup of S. 830, I received a 
letter from Secretary Shalala outlining the Department's key concerns. 
This was sometime ago. In her letter, the Secretary stated:

       I am concerned that the inclusion of nonconsensus issues in 
     the committee's bill will result in a protracted and 
     contentious debate.

  Before and since our committee markup, we have worked hard to achieve 
a consensus bill. The measure before us today accomplishes that goal. 
Bipartisan staff and Members have worked diligently with the agency to 
address each of the significant nonconsensus provisions raised by the 
Secretary.
  In her letter, Secretary Shalala expressed her feeling that the 
legislation would lower the review standard for marketing approval. Key 
changes have been made to the substitute to address these concerns. 
With respect to the number of clinical investigations required for 
approval, changes were made to assure that there is not a presumption 
of less than the two well-controlled and adequate investigations, while 
guarding against the rote requirement of two studies.
  We made it very clear you don't have to do two, although it is quite 
acceptable for you to do two, but you shouldn't look at it as being 
required. It is not necessary.
  The measure clarifies that substantial evidence may, when the 
Secretary determines that such data and evidence are sufficient to 
establish effectiveness, consist of data with one adequate and well-
controlled clinical investigation and confirmatory evidence.
  Concerns were raised also about allowing distribution of experimental 
therapies without adequate safeguards to assure patient safety or 
completion of research on efficacy. Changes to accommodate those 
concerns were made. They are in the substitute. We tighten the 
definition of who may provide unapproved therapies and gave FDA more 
control over the expanded access process.
  Other changes will ensure that use of products outside of clinical 
trials will not interfere with adequate enrollment of patients in those 
trials and also give the FDA authority to terminate expanded access if 
patient safeguard protections are not met. The provision allowing 
manufacturers to charge for products covered under the expedited access 
provision was deleted also.
  In mid-June, the Secretary argued that S. 830 would allow health 
claims for food and economic claims for drugs and biologic products 
without adequate scientific proof. In response, Senator Gregg agreed to 
changes that would allow the FDA 120 days to review a health claim and 
provide the agency with the authority to prevent the claim from being 
used in the marketplace by issuing an interim final regulation.
  In addition, the provision allowing pharmaceutical manufacturers to 
distribute economic information was modified to clarify that the 
information must be based on competent and reliable scientific evidence 
and limited the scope to claims directly related to an indication for 
which the drug was approved.
  This bill was further changed to accommodate the Secretary's 
opposition to the provision that would allow third-party review for 
devices.
  Products now excluded from third-party review include Class III 
products. These are products that are implantable for more than 1 year, 
those that are life sustaining or life supporting, and also products 
that are of substantial importance in the prevention of impairment to 
human health.
  In addition, a provision advocated by Senator Harkin has been 
incorporated that clarifies the statutory right of the FDA to review 
records related to compensation agreements between accredited reviewers 
and device sponsors.
  I want to point out that we have been working hard with Members, the 
Secretary, and others who brought problems to us, and we believe we 
have all of those taken care of, but we understand now we will have to 
do some more work today.
  Finally, the Secretary was concerned about provisions that she felt 
would burden the agency with extensive new regulatory requirements that 
would detract resources from critical agency

[[Page S8164]]

functions without commensurate enhancement of the public health. This 
legislation now gives FDA new powers to make enforcement activity more 
efficient, adds important new patient benefits and protections, and 
makes the review process more efficient.
  First, we give FDA new powers and clarify existing authority, 
including mandatory foreign facility registration, seizure authority 
for certain imported goods, and a presumption of interstate commerce 
for FDA-regulated products. Those are all important changes to help 
clarify the powers of the FDA.
  Second, to assist patients with finding out about promising new 
clinical trials, we established a clinical trials database registry, 
accessed by an 800 number. Patients will also benefit from a new 
requirement that companies report annually on their compliance with 
agreements to conduct postapproval studies on drugs. This was an 
important provision that we added, working with Senator Kennedy.
  Third, FDA's burden will be eased by provisions to make the review 
process more collaborative. Collaborative reviews will improve the 
quality of applications for new products and reduce the length of time 
and effort required to review products. We also expressly allow FDA to 
access expertise at other science-based agencies and contract with 
experts to help with product reviews. This is very important to bring 
about more efficient and effective utilization of resources.
  Lastly, by expanding the third-party review pilot program for medical 
devices, we build on an important tool for the agency to use in 
managing an increasing workload in an era of declining Federal 
resources.
  In closing, I echo another part of Secretary Shalala's June 11 
letter:

       I want to commend you and the members of the committee on 
     both sides of the aisle on the progress we have made together 
     to develop a package of sensible, consensus reform provisions 
     that are ready for consideration with reauthorization of the 
     Prescription Drug User Fee Act. . . a protracted and 
     contentious debate . . . would not serve our mutual goal of 
     timely reauthorization of PDUFA and passage of constructive, 
     consensus bipartisan FDA reform.

  I can't tell you how pleased I am that we have been able to work with 
the Secretary and come to this point now where we have few--I don't 
believe we have any disagreements--with the Secretary. Although we have 
some further matters we may have to discuss.
  From the beginning of this process, all of the stakeholders have been 
committed to producing a consensus measure, and we have accomplished 
that goal. There is agreement on this bill, and I urge my Democratic 
colleagues to allow this important measure to move forward.
  Before yielding the floor, I would like to commend the members of the 
committee. I have never worked with a group that has worked as hard as 
the members of my committee have to bring about a consensus. This has 
been night-and-day work for weeks. We have some outstanding Members on 
both sides of the aisle that have done outstanding work to bring us to 
this point. I could name them all, and I will eventually as we go 
forward, but I know standing and ready to go is one of those who has 
been of invaluable service to this committee. That is Senator Frist. 
With his knowledge as a physician, his intelligence and ability to 
communicate in a way that brings about consensus, we have moved forward 
on some incredibly important goals for being able to assist our doctors 
in their pursuance of good health for all of us.
  With that, Mr. President, I yield the floor.
  Mr. FRIST addressed the Chair.
  The ACTING PRESIDENT pro tempore. The Senator from Tennessee.
  Mr. FRIST. Mr. President, I rise to speak on the issue of a bill 
which I am very hopeful will be considered shortly, and that is the 
Food and Drug Administration Modernization and Accountability Act of 
1997. I came to the floor expecting, as we all had anticipated, that 
this bill would be considered today in the bipartisan spirit that has, 
in many ways, been reflected by working together over the past 2 years 
on a bill that will modernize the FDA, will strengthen the FDA and 
will, what I guess I care most about, improve patient care for the 
thousands, for the hundreds of thousands of people who will benefit 
from having speedier access to effective drugs, to effective therapies, 
to effective devices.
  I am very excited about the bill, yet I am very disappointed now that 
my colleagues on the other side of the aisle have presented a situation 
where this bill cannot be considered today.
  I am hopeful that over the course of today we will be able to reach 
some sort of agreement. I had thought we had reached that agreement, 
but obviously we have not, much to my disappointment and, I think, to 
the detriment of the United States and all those people who could 
benefit from having a strengthened FDA.
  A comment was made earlier that the bill has not really been 
considered by a number of people. Again, that is a bit disappointing. 
The bill before us today really represents over 2 years of work 
conducted in committee and with people off of the committee that we 
just heard our distinguished chairman mention--2 years of work with one 
objective; that is, to modernize the Food and Drug Administration. I do 
want to emphasize the bipartisanship in committee, in the Human 
Resources Committee.
  This bill was considered, was marked up, and the bill, with a 14 to 4 
vote, passed out of committee to be taken to the floor. Throughout this 
process, our distinguished chairman, who we just heard from on the 
floor, has worked with the minority staff, with the minority Senators 
as well as the majority. Both Senator Jeffords and the majority, and 
Senator Kennedy and the minority on the committee have negotiated in 
good faith to move forward.
  During the months--and really this has gone on for months, in effect, 
for 2 years as we debated and discussed a very similar bill--but during 
the months leading up to committee passage--again, it has gone through 
the committee with a vote of 14 to 4--and continuing up to today, there 
have been a series of meetings between the FDA, between industry, 
between the administration and the committee staff, all gathered 
together in a bipartisan spirit, legislative and executive branch, 
working together to clarify provisions, to outline and to resolve those 
concerns between the various parties. And with a bill that is this 
major, that will impact every single American both in the current 
generation and in the next generation, it takes that working together, 
negotiating across the table, listening to everybody's concerns.
  I am delighted--up at least, I thought, until 15 or 20 minutes ago--
that those provisions had been discussed, that the debate had been 
outlined with negotiations and compromise carried out to where we have 
a very strong bill that will benefit all Americans.
  The chairman of the committee, through which this passed again with a 
strong bipartisan vote, pointed out the importance of passing FDA 
reform over the next 6 to 7 days, or I guess the remaining 5 days now, 
when he referred to the expiring authorization of what is called PDUFA. 
This is favored.
  The reauthorization, which is expiring--the authorization is 
expiring--the reauthorization is supported by the FDA, it is supported 
by the U.S. Congress, it is supported by the administration, and it is 
supported by industry. This law has been a great success. It must and 
will be extended for another 5 years. It is an integral part of the FDA 
reform and modernization bill that I hope will be introduced this week.
  If in some way this aspect of the bill is blocked, despite the fact 
that both sides--that all sides--want it to move forward, there is the 
potential that as many as 600 FDA reviewers that are employed because 
of PDUFA, which speeds up, which accelerates the approval process to 
get drugs out to the American people, could be at jeopardy. That must 
be addressed this week. Furthermore, patients awaiting the drugs that 
will be approved at an expedited rate of PDUFA will wait and wait and 
wait if this is not continued.


                         Privilege Of The Floor

  Mr. President, at this juncture, I ask unanimous consent that 
privileges of floor be granted to a member of my staff, Dr. Clyde 
Evans, during the period between now and 3 p.m., Monday July 28.

[[Page S8165]]

  The ACTING PRESIDENT pro tempore. Without objection, it is so 
ordered.
  Mr. FRIST. Mr. President, I would like to speak to a specific aspect 
of the bill that reflects, I think, the bipartisan spirit, the working 
together to the benefit of individual patients or future patients, to 
the benefit of children today, of hard-working men and women across 
this country. It has to do with the whole topic of dissemination of 
scientific medical information. This aspect of the Food and Drug 
Administration Modernization and Accountability Act of 1997 is a very 
important one, but one that has been contentious in many ways and in 
many people's minds has been the most contentious part of the FDA bill.
  It all stems back to legislation that was introduced by my 
distinguished colleague from Florida, Mr. Mack, and myself 2 years ago. 
It focuses on the fundamental aspect which is so important to the 
practice of medicine today, to the delivery of care today, and that is 
to allow a free flow of good, accurate information that can be used to 
benefit people who need health care and health care services. It 
focuses on the dissemination of scientific medical peer-reviewed 
information to physicians and other health care providers.
  As I said, this is an important aspect of the bill which I hope will 
be introduced. It will result in more scientific information on uses of 
FDA-approved drugs in an off-label or extra-label manner. Again, these 
are products that have already been approved by the FDA, but they are 
used very commonly in fields such as pediatric medicine, the practice 
of delivering care to children today while they are in the hospital, 
used very commonly in the treatment of cancer therapy. As much as 90 
percent of all of the uses of drugs in oncology or the treatment of 
cancer are used in what is called an off-label or extra-label manner.
  These provisions, which are a part of the underlying bill, represent 
a lot of hard work, as was implied by the distinguished chairman, a lot 
of bipartisan support which has been demonstrated especially over the 
last 2 months but really over the last 6 months.
  Specifically, I want to thank my colleagues on both sides of the 
aisle, Senator Mack, who I mentioned, Senator Dodd, Senator Wyden and 
Senator Boxer, all of whom have remained throughout committed to this 
issue and have demonstrated real leadership in their bipartisan working 
together to come up with a piece of legislation that will be to the 
benefit of all Americans. I, too, want to express my appreciation to 
Secretary Shalala for her willingness to work, along with Senator 
Kennedy, on what had been considered, as I mentioned, one of the most 
contentious issues initially of FDA reform. Now we have a bipartisan 
consensus agreement among all parties in this body with the FDA and 
with the administration.
  The information dissemination provisions do represent a compromise, a 
balanced compromise, but they really ultimately respect the importance 
of physicians receiving up-to-date, independently derived scientific 
information, as well, at the same time to pursue, when possible, 
getting those prescribed uses ultimately approved on the label by the 
FDA. Thus, we have to address the dissemination of information. But 
what we have come to by these very careful, balanced negotiations is 
this linkage to actually improving and reforming the supplemental 
application process. The goal among almost all of us is to get as many 
of these uses today on the label.
  Now, what does off-label mean? Off-label scares people. As a 
physician, as someone in my thoracic oncology practice, as someone who 
routinely every week treated cancer patients, I have some 
responsibility to define for my colleagues what off-label means. Off-
label scares people. Is it somebody going in some secret closet and 
pulling out a medicine and using it? No, it is not. That is why extra-
label is probably a better term. But right now off-label is something 
that we in the medical profession understand is used routinely in the 
pediatric population and, as mentioned earlier, for inpatient 
hospitalization. Probably 50 percent of all pediatric drugs prescribed 
are off-label. So it is not a term to be scared of or to fear.
  In off-label use, it is simply the use of a drug which has been 
approved by the Food and Drug Administration in a way that has not yet 
specifically been indicated on the label. It might be using that drug 
in a combination with other drugs for an intended benefit. It might be 
a different dosage of that drug. It really comes down to the standpoint 
that the halflife of medical knowledge is moving quickly. We all know 
that.
  We know how fast science is moving, how fast medical information is 
changing. That change is skyrocketing and accelerating over time. 
Clearly, you have an FDA which, and appropriately to some extent, has 
to be very careful, has to rely on large clinical trials, and has not 
been as good historically in the past as we would like for it to be in 
terms of approving over time. That FDA cannot approve every single use 
of every single drug in the field of health and science which is moving 
at skyrocketing speed, accelerating speed.
  An example, aspirin, has been used off-label for years to prevent 
heart attacks. People generally know today taking a baby aspirin today 
or an aspirin every other day is effective in preventing heart attacks 
in certain populations. But right now, if you read on the label, there 
are certain limitations as to the use of aspirin. It is not specified 
that aspirin can be used prophylactically to prevent heart attacks 
today.
  Another example which reflects the importance of off-label or extra-
label use in a world where science is moving very quickly is that of 
the use of tetracycline. When I was in medical school, even 10 years 
ago, the whole theory of ulcer disease was based on a component of 
acid. Acid clearly plays a very important role, but what we did not 
know--in fact when I first heard it myself when I was a resident, I 
said, ``No way; impossible.'' But what was figured out is that 
antibiotics can help cure ulcers because the etiology of ulcer disease, 
of certain types of ulcer disease, is based on a bacterium.
  Well, we know that today. Yet tetracycline and the use of 
tetracycline, a very common antibiotic which is used for many other 
reasons, does not have an on-label use for the treatment of ulcers. Yet 
there are thousands of people right now taking tetracycline to treat 
their ulcer disease--that is an extra- label use, an off-label use--
under the law, of course. With 90 percent of my oncology patients using 
off-label-use drugs, with 50 percent of my pediatric patients using 
off-label drugs, with tetracycline, physicians are allowed legally, of 
course, to use and prescribe drugs for off-label uses.

  In addition to being a thoracic oncologist--and I will have to add 
that I was codirector of the thoracic, which is chest, oncology cancer 
treatment; and lung cancer is the No. 1 cause of cancer death in women 
today--that for the medical treatment of thoracic cancers, of lung 
cancer, well over 95 percent of the treatment is off-label today.
  In my field of heart and lung transplant surgery, many of my patients 
are alive today, of the hundreds of patients whom I have transplanted, 
because of the off-label uses of FDA-approved drugs. Then, in my 
routine heart surgery practice, where I have put hundreds of mechanical 
valves in patients over the last several years, there is another great 
advantage of off-label drugs.
  About 40 years ago, the first mechanical heart valves were put in to 
replace defective valves scarred by rheumatic heart disease. These 
mechanical valves are replaced routinely. This started in the early 
1960's, about 40 years ago. But it was not until March 31, 1994, just 3 
years ago, that the off-label use of Coumadin, the blood thinner which 
all these patients are on and have been on for the last 35 years, that 
it was ultimately approved for on-label use, according to FDA.
  It has been clear in the literature and among my colleagues that 
Coumadin, this blood thinner, is not only important, but lifesaving for 
those who have received medical valves. So dissemination of information 
is important. It is important for physicians to be able to have the 
latest information, to have the free flow of information. Why? In order 
to best treat, using the latest techniques and the most effective 
therapy, the patients who come through their door that they treat in 
the hospital. Dissemination of information,

[[Page S8166]]

with appropriate balance and disclosure, will allow sharing of this 
type of information with physicians and with other people who can take 
advantage of it.
  Let me just close with one further explanation about why it is 
important. We are talking about this information going to people who 
are trained to consider this information. Right now, there are barriers 
there, which means if I were a physician practicing in rural Tennessee, 
I am not likely to be going to Vanderbilt or the local academic health 
center and participating in conferences every week. If I am in rural 
Tennessee, where do I get my information? I get it from what I learned 
in medical school, but there is a problem with that because we already 
said the half-life of medical knowledge is shorter and shorter, with 
the great discoveries that we have today. I am most likely to read 
medical journals. Yes, there are many, many journals that it is 
important for me to read to keep in touch with. I could search the 
Internet. But to be honest with you, your typical physician is so busy 
today delivering care, it is very unlikely that they are going to sit 
down at a computer terminal in rural Tennessee and go to the Internet 
and get information.
  In fact, last year, in testimony before the Labor Committee, Dr. 
Lindberg at the National Library of Medicine testified before the 
committee, and explained how vast this literature is out there. He was 
talking about MEDLINE, which is the primary medical database that is 
used, in which all of the peer-reviewed journals are placed on this 
computerized data base. He explained the challenge that physicians have 
today in the following way:

       MEDLINE contains more than 8 million articles from 1966 to 
     the present. It grows by some 400,000 records annually. If a 
     conscientious doctor were to read two medical articles before 
     retiring every night, he would have fallen 550 years behind 
     in his reading at the end of the first year.

  Now, in medicine, where one's health and one's life is in the hands 
of the physician, I don't see how people can argue about free and 
appropriate dissemination of information to best benefit that patient, 
to take care of you as an individual. Yet, there are barriers there. 
We, probably unintentionally, over time, have created barriers that now 
we need to take down, to allow the appropriate and balanced 
dissemination of information to be to the benefit of that physician who 
is going to be seeing my colleagues, their children and their spouses 
in the future. More information, I feel, is better, as long as it's 
balanced, peer-reviewed, and safeguards are built in to make sure that 
it is not used for promotion.
  Mr. President, I will yield the floor soon. This is an issue that I 
really want to just underscore this day because it represents 
bipartisanship, working together with the distinguished colleagues on 
both sides of the aisle. It started from a bill that was introduced in 
the Senate by the Senator from Florida [Mr. Mack], and myself. It has 
been greatly improved. How? By sitting around the table with the 
administration, with the FDA, with colleagues on both sides of the 
aisle to the point that we, when we pass the overall bill, will be able 
to improve the health care of individuals across this country.
  I feel this is one of the most important aspects of this bill. Again, 
I call on my colleagues on both sides of the aisle to come together so 
that we can bring up the underlying bill and pass it to the benefit of 
all Americans.
  I yield the floor.
  Mr. WYDEN addressed the Chair.
  The ACTING PRESIDENT pro tempore. The Senator from Oregon is 
recognized.
  Mr. WYDEN. Mr. President, I strongly urge my colleagues to join today 
in bipartisan support for this important piece of legislation. In doing 
so, I want to commend Chairman Jeffords, in particular, and Members on 
both sides of the aisle, because this bill, in my view, meets the 
central test for good FDA reform legislation. An FDA reform bill ought 
to keep the critical safety mission for the Food and Drug 
Administration, while at the same time encouraging innovation--
innovation that is going to produce new therapies and save lives. This 
bill meets that twin test.
  This bill is a result of, as several of our colleagues have noted, 
much debate and an extraordinary effort to build consensus. I am proud 
to have played some part in that effort as a Member of both the House 
of Representatives and the U.S. Senate, having introduced, more than 2 
years ago, H.R. 1472, the FDA Modernization Act, which contains several 
of the key ingredients of the legislation before us today.
  Mr. President, from the time we get up in the morning until the time 
we go to bed at night, we live, work, eat, and drink in a world of 
products that are affected by decisions made at the Food and Drug 
Administration. Perhaps no other Federal agency has such a broad impact 
in the daily lives of average Americans.
  Food handling and commercial preparation often occurs under the 
agency's scrutiny. Over-the-counter drugs and nutritional supplements, 
from vitamins to aspirin, are also certified by the agency.
  Life-saving drugs for treatment of cancer, autoimmune deficiency, and 
other dreaded diseases, are held to its rigorous approval standards.
  Medical devices ranging from the very simple to the complex, from 
tongue depressors to computerized diagnostic equipment, all have to 
meet quality standards at the FDA.
  These products that are overseen by the FDA are woven deeply into the 
fabric of our daily lives, and the agency's twin missions of certifying 
their safety and effectiveness is supported by the vast majority of 
Americans.
  Yet, balancing those missions against the time and expense required 
by companies to navigate the FDA approval system has often been 
difficult and controversial. In the last Congress, radical 
transformation of the agency, even ending the agency as we know it and 
replacing it with a panel of private sector, expert entrepreneurs, 
became a goal of some.
  At the very least, reforming the Food and Drug Administration at the 
beginning of the last Congress looked to be an exercise fraught with 
partisan political turmoil, and destined for ongoing gridlock.
  But while there was focus on the extreme ends of the argument--those 
folks arguing for no changes against Members demanding wholesale 
dismemberment of the agency--a broad, bipartisan group of Members of 
Congress developed.
  With the help of Vice President Gore's Reinventing Government 
Program, Members of Congress from both political parties developed 
practical, bipartisan solutions to the critical management issues that 
the FDA approval process presents.
  I sought to mobilize this bipartisan movement with H.R. 1472, 
introduced in June 1995. Some in my party thought I had gone too far, 
too fast. But I am gratified that many of the elements of this 
legislation, strengthened in this legislation, are going to be 
considered by the Senate.
  These include, first, a streamlining of approval systems for 
biotechnology product manufacturing. It is clear that the rules for 
biotechnology, so central to health care progress, have not kept up 
with the times. This legislation will allow biotechnology to move into 
the 21st century with a realistic framework of regulation.
  The bill allows approval of important new breakthrough drugs on the 
basis of a single, clinically valid trial.
  It creates a collaborative mechanism allowing applicants to confer 
constructively with the FDA at critical points in the approval process.
  It sets reasonable, but strict, timeframes for the approval of 
decisionmaking.
  It reduces the paperwork and reporting burden now facing so many 
small entrepreneurs when they make minor changes in the manufacturing 
process.
  It establishes provisions for allowing third-party review of 
applications at the discretion of the Secretary.
  It allows manufacturers to distribute scientifically valid 
information on uses for approved drugs and devices, which have not yet 
been certified by the Food and Drug Administration.
  Each of those areas, Mr. President, was in the legislation that I 
introduced more than 2 years ago, and with the bipartisan efforts that 
have been made in this bill, each of them has been strengthened. I am 
especially pleased that Senators Mack, Frist, Dodd, Boxer, Kennedy, and 
I could offer the provisions of this legislation relating

[[Page S8167]]

to the dissemination of information on off-label uses of approved 
products.
  This provision will allow manufacturers to distribute scientifically 
and clinically valid information on such uses following a review by the 
Food and Drug Administration, including a decision that I proposed more 
than 2 years ago, which may require additional balancing material to be 
added to the packet.
  Here is why that is important. Manufacturers with an approved drug 
for ovarian cancer may have important, but not yet conclusive, 
information from new trials that their drug also may reduce brain or 
breast cancers. That data, while perhaps not yet of a grade to meet 
supplemental labeling approval, may be critically important for an end-
stage breast cancer patient whose doctor has exhausted all other 
treatments.
  That doctor and that doctor's patient have the absolute right to that 
information. It is time for this policy of censorship at the Food and 
Drug Administration to end. I believe that, with the legislation that 
will come before the Senate, it will be possible for health care 
providers to get this critical information and do it in a way that 
protects the safety of all of our citizens.
  This legislation is going to save lives, not sacrifice them. It is 
going to mean that more doctors and their patients will have meaningful 
access to life-saving information about drugs that treat dread diseases 
like HIV and cancer.
  It will mean that biologic products will have a swifter passage 
through an approval process which no longer will require unnecessarily 
difficult demands with regard to the size of a startup manufacturing 
process.
  It will mean that breakthrough drugs that offer relief or cures for 
deadly diseases, for which there is no approved therapy, are going to 
get to the market earlier on the basis of a specially expedited 
approval system.

  Mr. President, legislation, indeed laws, are only words on paper. Mr. 
President, we must also have a new FDA Commissioner who is committed to 
the changes in S. 830, just as committed to those changes as former 
Commissioner David Kessler was committed to the war on teenage smoking.
  This bill goes a long way to making sure that the Food and Drug 
Administration is prepared to meet the challenges of the 21st century. 
But we also need to make sure that at the FDA, at that agency, there is 
a new commitment at every level to carry out these changes.
  I believe that it is possible to keep the mission of the Food and 
Drug Administration--that all-critical safety mission, a mission that 
Americans rely on literally from the time they get up in the morning 
until the time they go to bed at night--while still ensuring that there 
are opportunities for innovation in the development of cures for dread 
diseases.
  Mr. President, I also want to conclude by thanking a member of my 
staff, Mr. Steve Jenning. For several years now, he has toiled on many 
of these provisions with Members of Congress on both the House side and 
the Senate side, to help bring about this legislation. He has, in my 
view, done yeoman work, and I want to make sure that the Senate knows 
about his efforts. I know my colleagues in the House are very much 
aware of him.
  So we all look forward, on a bipartisan basis, to seeing S. 830 come 
to the floor. It is a bill that is going to make a difference in terms 
of saving lives. The Senate needs to pass it and needs to pass it this 
week.
  Mr. President, I yield the floor.
  Mr. JEFFORDS addressed the Chair.
  The ACTING PRESIDENT pro tempore. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, first of all, I want to thank the 
Senator from Oregon for his support and for his very effective 
presentation. I know there are so many of us here who want to work 
together. In fact, just about everybody does. That is why it is of such 
concern to me that we now find ourselves in a position where we can't 
proceed. I know of the Senator's immense assistance in helping us in 
this matter, and I appreciate what he has said.
  Mr. President, I think it would be wise at this point, while we are 
biding time in the hopes of being able to move forward, to answer the 
questions that many people have: Why are we here? What is the big deal? 
What is so important? Why are we anxious to get moving and to get this 
piece of legislation passed?
  I would like to go through some of the problems that we have right 
now with the FDA because it is our lives and our health that are at 
stake here. The time delays that occur because of the various problems 
at the FDA that we are trying to correct mean that new therapies that 
would be essential to your life and health, proceed so slowly that 
many, many people are deprived of the hopes and dreams we all have of a 
good health and a good life.
  Let me provide some examples. By law, FDA is required to review and 
act on applications for approval on drugs within 180 days. Now, that 
180 days was not just pulled out of the air. That was looking at the 
normal processes you would be able to do it in 180 days. According to 
FDA's own budget justification for fiscal year 1998, it takes the 
agency an average of 12 months longer than the statute allows to 
complete this process. It takes, on average, a year and a half for a 
process that should take 6 months.
  Since the 1960's to the 1990's, complete clinical trials, that is, 
the time required by FDA to show for efficacy of drugs, has increased 
from 2.5 to nearly 7 years. Between 1990 and 1995, the FDA average 
approval time, that is, the time after the clinical trials have been 
completed, was about 2.3 years.
  Today, only 1 in 5,000 potential new medicines is ever approved by 
the FDA. According to a recently published study, from the beginning of 
the process to the end, it takes an average of 15 years and costs in 
the range of $500 million to bring a new drug to market.
  Why does this process take so long? Before FDA even gets involved in 
the process, innovators spend an average of 6\1/2\ years in early 
research and preclinical testing in the laboratory and with animal 
studies. Long before human tests begin, a summary of all the 
preclinical results is submitted to the FDA. This document, known as 
the investigational new drug application, or IND, contains information 
on chemistry, manufacturing data, pharmacological test results, safety 
testing results and a plan for clinical testing in people.
  If the FDA judges the potential benefits to humans to outweigh the 
risks involved, the stage is set for three phases of clinical trials to 
begin. Taken together, the three phases of clinical trials in human 
populations average about an additional 6 years.
  Phase I clinical trials focus on safety. During about a 1-year 
period, very low doses of compound are administered to small groups of 
healthy volunteers. Gradually, they are increased to determine how the 
bodies react to the different levels.
  Phase II clinical trials last about 2 years; that is, 2 additional 
years. They involve 100 and 300 patient volunteers, and focus on the 
compounds effectiveness. These are blinded trials that are held in 
hospitals around the country where they compare the innovator compound 
with a so called placebo--that is the control group is not given 
anything. The effect of the innovator drug is compared with effect on 
those who received the placebo. Three out of four prospective drugs 
drop out of the picture as a result of the data collected during these 
phase II trials.
  Phase III trials involve one or more clinical trials where 
researchers aim to confirm the results of earlier tests in a larger 
population. Phase III lasts from 2 to 5 years and can involve between 
3,000 and 150,000 patients in hundreds of hospitals and medical 
centers. These tests provide researchers with a huge database of 
information on the safety and efficacy of the drug candidate to satisfy 
FDA's regulatory requirements.
  The amount of data required to file for the next new phase, new drug 
application, or NDA, is staggering. The application for new drugs 
typically runs to hundreds of thousands of pages in length. For 
example, in 1994, the NDA for a groundbreaking arthritis medication 
contained more than 1,000 volumes of documentation that weighed 3 tons. 
It included data from clinical tests in roughly 10,000 patients, some 
of whom had been taking new medication 5 years.
  During the NDA review process--which can last an additional 2\1/2\ 
years, Government officials have extensive

[[Page S8168]]

contact with the company. They visit the research facilities and talk 
to the doctors and scientists involved in the research. In addition, 
FDA officials visit and approve the manufacturing facilities and review 
and approve all the labeling, packaging and marketing that will 
accompany the product.
  Well, that is good and we want the FDA to be thorough, but things can 
be done more efficiently and more effectively. If we cannot reduce 
these times based on the consensus agreements in this bill--then a lot 
of people will lose the timely availability and the utilization of 
these breakthroughs.

  What does this reducing of overall time mean for Americans? If we can 
reduce this overall time, it means quicker access to safe and effective 
lifesaving drugs.
  I want to point out that the FDA, when it reviewed priority 
applications, has been able to make breakthroughs in AIDS and elsewhere 
by just being more efficient.
  Also, for instance, to give you an example of review process delay, 
over 12 million type-2 diabetics had to wait almost 2 years for a new 
machine to be approved. Almost 2 million American women with breast 
cancer had to wait almost 2 years in excess of what should have been 
required for this review process.
  So when that you have that kind of delay, you know you have to have 
reform, and that is why we are here. Some may argue that the long 
period of review and approval time is the price we pay for ensuring 
drug safety and efficacy. But that long delay does not hold true for 
all drugs. We know the FDA can significantly reduce its approval times 
because it has already done it. We have, for instance, with respect to 
the AIDS therapies, the so-called protease inhibiters that were 
approved in a matter of months. FDA can do more to ensure that they 
receive timely attention, and S. 830 will help FDA do so for all 
promising therapies. FDA is aware of this, and that is why they have 
been working to help simplify the law, simplify the process, simplify 
the procedures, so that we can get these drugs to market on time 
without in any way infringing upon the necessity to protect the health 
of our people.
  So as we proceed, I will review these issues in a more definitive 
manner. But as we await removal of an objection to proceed, I just 
wanted to remind people that there are real, valid, deep concerns that 
we are facing here. Our goal is to make sure the health of our Nation 
can improve and that people will be able to have access to the 
innovative therapies that will benefit their lives.
  Mr. President, I yield the floor.
  Mr. FRIST addressed the Chair.
  The PRESIDING OFFICER (Mr. Thomas). The Senator from Tennessee.
  Mr. FRIST. Again, I would like to commend the chairman of the Labor 
and Human Resources Committee for the outstanding work he has done in 
shepherding through the committee and now, hopefully, later today bring 
to the floor an act which will modernize and strengthen the FDA and 
will be to the real benefit of all Americans to make sure that health 
care services are given in an expeditious way to the American people.
  As I mentioned in my earlier comments in the Chamber, a central 
aspect of health care today is the dissemination of information to 
physicians, to health care providers so that both will know, understand 
and have access to and be able to use appropriately that information to 
serve their patients, the so-called off-label or extra-label provisions 
I introduced this morning, and I want to share once again my delight in 
the fact that in a bipartisan way, working with Senators Kennedy, 
Wyden, Boxer, Mack, myself, and the distinguished chairman, we have 
come together and worked with the administration and the FDA to address 
this very important issue of dissemination of information.
  As I mentioned, off-label uses are really prominent in health care 
today. The American Medical Association estimates the off-label or 
extra-label use of drugs that have already been approved by the FDA to 
be in the range of 40 percent to 60 percent of all prescriptions. Of 
all prescriptions written today, 40 to 60 percent are estimated by the 
American Medical Association to be off-label, and there have been very 
few problems associated with this off-label appropriate use. In 
treating hospitalized children, it has been estimated that over 70 
percent of the drugs are prescribed to be off-label, and that can vary 
anywhere from 60 to as high as 90 percent, and for diseases such as 
cancer the figure can be as high as 90 percent.
  As a lung cancer surgeon--I mentioned earlier the treatment of lung 
cancer today--the medical treatment of lung cancer involves well over 
80, more in the range of 90, percent of all medical treatment being 
off-label. And that is that the drugs already approved by the FDA are 
used either in a dosage or in a combination with other drugs that have 
not yet been approved or studied through the FDA process. That can be 
improved in lots of ways and that is part of the underlying bill, to 
strengthen the FDA by making the approval process more efficient. 
People ask me frequently, why aren't all uses of drugs, if they are 
really effective, if they are really valuable, if they really improve 
patient care, why aren't they on the label?

  A goal of all of us, I think, is to get as many on the label as 
possible. But in answering that question, I first cite the American 
Medical Association's Council on Scientific Affairs, which met this 
spring to consider all of these issues and to make recommendations 
regarding information dissemination and what we call the supplemental 
approval process; that is, a drug has been approved for a specific 
indication at a specific dose and if it is discovered through medical 
science that a different dose or another medication is in order, why 
can't you get that in a supplemental way on the label. The AMA's 
Council on Scientific Affairs, in explaining why there are currently so 
many medically accepted, commonly used, unlabeled uses of FDA-approved 
drugs, states:

       The simple answer is that FDA-approved labeling does not 
     necessarily reflect current medical practice.

  In their comments, they go on to explain that manufacturers may not 
seek FDA approval for all useful indications for a whole range, a whole 
host of reasons, including:

       The expense of regulatory compliance may be greater than 
     the eventual revenues expected--e.g. if patent protection for 
     the drug product has expired or if the patient population 
     protected by the new use is very small.

  The point is, if you have a drug in your pharmaceutical company and 
you know it is good, yet it will benefit very few people in a 
population and you know it is going to cost you millions and millions 
of dollars and years and years of trying to put through these clinical 
trials, what incentive do you have when the benefit is to such a few 
number of patients out there? Thus, we need to lower that barrier, make 
the supplemental approval process for these extra-label or off-label 
uses easier, lower that barrier.
  Patent protection. Once a manufacturer has invested a lot of money 
and time in clinical trials and meeting the regulatory requirements of 
the Food and Drug Administration, they are protected for a period of 
time through the patent, but once the patent expires, what then is 
their incentive to go out and get this off-label use put on the label 
when they have to go through so many hoops, through what all of us know 
is an inefficient process today?
  The good news is that the underlying bill addresses the supplemental 
process. It links off-label use or dissemination of information about 
off-label use to a future application.
  Now, the supplemental process--and what I am even more excited or 
equally excited about is it makes that supplemental process more 
efficient, with more incentives for the manufacturers to seek what is 
called a supplemental new drug application.
  Going back to the AMA's Council on Scientific Affairs, they say:

       A sponsor also may not seek FDA approval because of 
     difficulties in conducting controlled clinical trials. ([For 
     example,] for ethical reasons, or due to the inability to 
     recruit patients).

  ``Finally,'' and again I am quoting them:

       . . . even when a sponsor does elect to seek approval for a 
     new indication, the regulatory approval process for the 
     required [Supplemental New Drug Application] is expensive and 
     may proceed very slowly.

  In fact, they continue to explain a little bit later, that the past 
review

[[Page S8169]]

performance for SNDA's, Supplemental New Drug Applications, is

       . . . unexpected because the SNDA should be much simpler to 
     review than the original [New Drug Application], and suggests 
     the FDA gave much lower priority to reviews of SNDAs.

  The point is, we need to improve the underlying supplemental new drug 
application process and this bill does that as well. I am very hopeful 
that this bill can be brought to the floor because you can see the 
number of good things that are in this bill that will speed and make 
more efficient the overall approval process with safeguards built in 
that will protect the American people from dangerous drugs, the 
unnecessary side effects of drugs or devices.
  The underlying bill, again pointing to the real advantages of getting 
this bill to the floor, includes additional incentives for 
manufacturers to seek supplemental labeling, including added 
exclusivity for those seeking pediatric labeling. Again, encouraging--
and we know, if you look back historically, we as a nation have not 
done very well, in terms of aiming labeling for the pediatric 
population, a place where these drugs are so critical, are so crucial 
for our children, my children, your children. We need to do better 
there and this bill addresses that.
  Also, the underlying bill requires that the FDA publish performance 
standards for the prompt review of supplemental applications. It 
requires the FDA issue final guidance to clarify the requirements and 
facilitate the submission of data to support the approval of the 
supplemental application. And it requires the FDA to designate someone 
in each FDA center who will be responsible for encouraging review of 
supplemental applications and who will work with sponsors to facilitate 
the development of--and to gather the data to support--these 
supplemental new drug applications. Moreover, the Secretary, as 
specified in the bill, will foster a collaboration between the Food and 
Drug Administration and the NIH, the National Institutes of Health, and 
the professional medical societies and the professional scientific 
societies, and others to identify published and unpublished studies 
that could support a SNDA, a supplemental new drug application. The 
point is to improve that communication, that working together. Finally, 
in the bill, the Secretary is required to encourage sponsors to submit 
SNDA's or conduct further research based on all of these studies.
  Again, this drives home the point that the underlying value of this 
bill dictates that it be brought forward to the floor, that it be 
debated, that it ultimately be passed and taken to the American 
people--all of these provisions which I cited--to improve the FDA's 
commitment to the SNDA process, to improve the agency's communication 
with manufacturers regarding the requirements for SNDA's, and the 
requirements that in most cases the manufacturers submit approved 
clinical trial protocols and commit to filing a SNDA before 
disseminating scientific information about off-label uses--all will 
improve the number of supplemental indications pursued by 
manufacturers.
  To be certain of the impact of all of these provisions, the 
dissemination provisions sunset after a completion of a study by the 
Institute of Medicine to review the scientific issues presented by this 
particular section, including whether the information provided to 
health care practitioners by both the manufacturer and by the Secretary 
is useful, the quality of such information, and the impact of 
dissemination of information on research in the area of new uses, 
indications, or dosages. Again, special emphasis in the bill is placed 
on rare diseases and is placed on pediatric indications.
  Indeed, limiting information dissemination to off-label uses 
undergoing the research necessary to get it on label has been a real 
subject of negotiation and compromise in this bipartisan discussion 
with the FDA and the administration and representatives from Congress. 
However, the point is that we have done that. It is now ready to be 
brought to the floor, to be talked about among all of our colleagues if 
they so wish. Those negotiations and those compromises have been 
carried out. It is time now to bring that to the floor. We have worked 
to accommodate many other concerns of our fellow colleagues in the U.S. 
Senate, concerns among the FDA and other organizations. The provisions 
outlined in the amendment have changed a great deal from the original 
bill that was proposed by Senator Mack and myself during the 104th 
Congress, and it makes it a better bill, a stronger bill, one that I 
think will benefit all Americans.
  In general, in the bill, manufacturers will be allowed to share peer-
reviewed medical journal articles and medical textbooks about off-label 
uses with health care practitioners only if they have made that 
commitment to file for a supplemental new drug application within 6 
months, or if the manufacturer submits the clinical trial protocol and 
the schedule for collecting the information for this new drug 
application, this supplemental new drug application. If those criteria 
are met, manufacturers will be allowed to share peer-reviewed medical 
journal articles and medical textbooks.

  I have to comment on peer review because it is important. That means 
the types of materials that are submitted, that a manufacturer may 
submit to a physician--remember the physician already has 4 years of 
medical school, several years of residency, is trained to at least read 
that peer-reviewed article. If that peer-reviewed article is sent, that 
dissemination of information will facilitate, I believe, the overall 
care of patients--broadly.
  In addition, the FDA will review whatever proposed information is to 
be sent out by a manufacturer to a physician. They will have 60 days to 
review that peer-reviewed article or that chapter out of a textbook. 
The manufacturer--and it is spelled out in the bill--must list the use, 
the indications--the indication, or the dosage provisions that are not 
on the label. The manufacturer must also disclose any financial 
interest. The manufacturer must also submit a bibliography of previous 
articles on the drug or the device. And, then, after all that 
submission, if the Secretary determines that more information is 
needed, she may require the manufacturer to disseminate other 
information in order to present an objective view. In other words, we 
are not allowing manufacturers to send out articles which have any sort 
of bias or conflict of interest. These are peer-reviewed articles with 
safeguards built in to make sure that there is not an undue bias.
  The safeguards against abuse also ensure that the information is 
accurate; it is unbiased when it is presented to that practitioner. 
Manufacturers must inform the Secretary of any new developments about 
the off-label use, whether those developments are positive or whether 
they are negative. And, in turn, the Secretary may require that new 
information be disseminated to health care practitioners who previously 
received information on a new use. This really should go a long way to 
ensure that health care practitioner--the person who is in rural 
Tennessee--is fully informed, with peer-reviewed articles, cleared of 
any conflicts of interest, with the FDA having had 60 days to make sure 
that balance is there.
  There are a number of benefits to this amendment. Patients will gain 
from better and safer health care because their physician will be more 
knowledgeable about potential treatments. That is the most important 
thing for a physician. Again, as I am in this body I want to keep 
coming back, again and again, to what is important to physicians and to 
our health care system. It is simply one thing and that is the patient; 
that the patient has access to the very best health care, the very best 
device to treat their cancer, to treat their underlying heart disease, 
to provide the patient with the very best possible care.
  There will be a number of charges, and there have been in the past, 
about this freedom of information, allowing dissemination of extra-
label information. One is--and we heard it last year and we built into 
the process, I think, very strong provisions to prevent this--but 
critics would say if you allow people to use drugs and devices off-
label--remember, that's the standard of care right now--but if you 
allow information to be disseminated by a manufacturer, then what 
incentive does that manufacturer have to go out and jump the hurdles of 
a SNDA, the supplemental new drug application process?

[[Page S8170]]

  Pharmaceutical companies are going to be committed to completing a 
SNDA in this bill. They have a greater incentive to continue research 
and clinical trials on their projects. The additional benefits of 
receiving approval for new indications include product reimbursement. 
Frequently you are not reimbursed for a medicine unless it is FDA 
approved. The incentive to get that approval is there if we have an 
appropriate barrier. Another is less product liability. Many people 
believe if it is on the label and you use that drug, that gives you 
some protection from product liability and therefore these 
manufacturers have an incentive to get that supplemental new drug 
application approved. Also, active promotion of the product for the new 
use.
  I also heard in the debate last year before the committee this whole 
idea of what peer review is. It is misunderstood by people broadly, but 
the concept of peer review is that I, as an investigator, submit my 
data and my studies to the experts in the world who are not 
necessarily--who are not, in fact--at my institution, not a part of my 
research team. They are objective. There is no conflict of interest. 
They review the study, they review the protocol, they review how the 
study was carried out, and decide is this good science or is this bad 
science. And that is what peer review is. Typically, journals that are 
peer-reviewed have objective boards that look at this data and either 
put on their stamp of approval--they don't necessarily have to agree 
with everything, but they have to say it is good science and the study 
was conducted in an ethical and peer-reviewed manner.

  So peer review is important. We have worked, again in a bipartisan 
way, in this bill, with the American Medical Association's Council on 
Scientific Affairs to agree on the definition of a quality peer-
reviewed journal article in order to ensure that high scientific 
standards are guaranteed; if a manufacturer sends out an article, it 
has been peer reviewed. And we spell out in the bill that manufacturers 
will only be allowed to send out peer-reviewed articles from medical 
journals listed in the NIH, the National Institutes of Health, National 
Library of Medicine's Index Medicus. These medical journals must have 
an independent editorial board, they must use experts in the subject of 
the article, and must have a publicly stated conflict of interest 
policy. Again, building in, as much as possible, the concept of 
educated scientifically objective peer review.
  Last, manufacturers will not be allowed to advertise the product. 
They will not be allowed to make oral presentations. They will not be 
allowed to send free samples to health care practitioners. In other 
words, sending a health care practitioner, a physician, an 
independently derived, scientifically significant peer-reviewed journal 
article is not promotion. As a physician, I know, reading a peer-
reviewed article--you see a lot of peer-reviewed articles--does not 
necessarily change my prescribing habits. As a physician, I am trained 
through medical school and residency and my years of practice to 
assimilate that information, reject what I don't agree with or what I 
don't think is good science and use, if I think it is in the best 
interests of my patient, what is suggested.
  In closing, let me simply say that I am disappointed that an 
objection has been made to bringing to the floor the large bill that 
will strengthen the FDA. It is important that we do so. It is important 
that we extend PDUFA, which is the approval process supported by the 
private sector, working hand in hand with the public sector, which has 
been of such huge benefit to patients. We should do so because we will 
be able to get better, improved therapies for the treatment of cancer, 
pediatric diseases, blood-borne diseases, to the American people in a 
more expeditious way, and that translates into saving lives.
  We need to bring this bill to the floor now. We have bipartisan 
support. We have debated it. It was approved in a bipartisan way 
through the Labor and Human Resources Committee. If we do so, we will 
be doing a great service to the American people.
  I yield the floor.
  Mr. JEFFORDS addressed the Chair.
  The PRESIDING OFFICER. The Senator from Vermont.
  Mr. JEFFORDS. Mr. President, I, again, want to thank Doctor --Senator 
Frist who is a cosponsor of this bill and has lent his incredible 
expertise to this effort. I especially thank him for his leadership, 
with Senators Mack, Boxer, and Wyden, for their work in solving the 
off-labeling provision. Their collaboration shows the broad base of 
support this provision now has. Off-labeling was one of the most 
contentious provisions in the last Congress. To come up with a solution 
of that issue is a tremendous step forward. I want to talk a little 
bit, before I wind things up here, about the broad base of support we 
have.
  Senator DeWine, for instance, joined with Senator Dodd in offering 
important amendments to establish incentives for the conduct of 
research into pediatric uses of existing and new drugs.
  Senator Hutchinson had an amendment to establish a national framework 
for pharmacy compounding with respect to State regulations which 
allowed us to move forward on another very contentious and important 
issue.
  I also want to praise and thank Senator Mikulski for being a 
cosponsor of this legislation, and the importance of her help on PDUFA, 
of which she was a primary sponsor. We all benefit from Senator 
Mikulski's determination to bring FDA into the 21st century, not just 
for the benefit of her own constituents, but for all of us.
  I also would like to point out that we had contributions by Senator 
Dodd in the area of patient databases. He worked very closely with 
Senator Snowe and Senator Feinstein. We are grateful for their 
leadership in these areas. Senator Dodd has been a tremendous asset in 
helping to enact broad-based reform this year. He has been of steady, 
continual assistance to us.
  Also, the tremendous difficulties that we had with third-party review 
provisions during the last Congress have undergone substantial revision 
since it was first debated. Senator Coats in particular has shown 
incredible leadership on this issue. This was a very difficult area and 
Senator Coats has been magnanimous in his willingness to spend many 
hours in bringing about consensus. I certainly appreciate his work.
  Senator Wellstone's contributions to the area of reforming medical 
device reviews shows the breadth of the philosophical collaboration we 
had on these issues. Senator Wellstone introduced his own legislation 
to reform the medical devices approval process and many of his 
provisions are included in this bill.
  Also, of course, Senator Kennedy has been of incredible help, as he 
has been on so many issues. He has worked hard and I thank him for the 
number of hours that he and his staff put into this bill to make sure 
we arrived at a consensus.
  I also thank Senator Gregg for working so hard on radio-
pharmaceuticals, on streamlining the process for reviewing health 
claims based on Federal research, and on establishing uniformity in 
over-the-counter drugs and cosmetics. The latter issue--cosmetic 
uniformity--is still giving us some trouble.
  But Senator Gregg has just been incredibly hard-working and effective 
with this bill in handling four different issues.
  Also, the two amendments that Senator Harkin had on the third-party 
review for medical devices and also his work in other areas has been a 
very great help and a demonstration of the broad philosophical support 
that we have and how we are working together to bring about a 
consensus, hopefully, before the end of the day on the remaining 
issues.
  Mr. President, before I cease, I would like to take care of a couple 
of housekeeping matters here.

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